Drapes are used during surgical procedures, in part, to provide a sterile field about the surgical site and during other treatment procedures requiring the maintenance of a sterile environment. When used during surgery, drapes prevent blood and other bodily fluids from cross contaminating the sterile field since the reinforcement areas are usually absorbent. If designed correctly, the absorbent area of a surgical drape facilitates cleanup and movement of the patient after the operative procedure.
A variety of surgical drapes exist, but most share several common features. Surgical drapes will have one or more openings or apertures (more commonly known in the medical field as "fenestrations") through which the surgical procedure is performed. Most drapes are made of a water-repellent or water-impermeable material, or are coated with such a material, to prevent passage of bodily fluids as well as contaminating microorganisms. Many of today's surgical drapes are made of disposable nonwoven fabrics, plastic film, or papers.
An adhesive material is normally attached to the periphery of the drape material that defines the fenestration(s) so that the drape can be held in place around the surgical site and so that blood will not pass between the drape and the patient's body. The combination of the drape itself and the adhesive material around the perimeter of the aperture ensures a barrier between the surgical wound and the remainder of the body.
Currently, both disposable non-woven as well as reusable woven surgical drapes are used to create the sterile field for operative procedures. Some drapes employ a primary base sheet in conjunction with a smaller sheet, or pad, that is often made of an absorbent material backed by a liquid impervious film. When used, the reinforcing, absorbent pad is superimposed over the larger base sheet and is often connected thereto with an adhesive. Both the base sheet and the smaller pad have one or more corresponding apertures which define the surgical sites. An example of a surgical drape with a reinforcing, absorbent pad is shown in U.S. Pat. No. 3,902,484 to Winters.
Cardiac catheterization and angiography procedures are surgical procedures that, due to their nature, present special requirements for a surgical drape. Cardiac catheterization is the introduction of a catheter (a long slender tube) into the heart in order to obtain information about the structure and function of the heart, the cardiac valves, the coronary arteries, and the like. The catheter is typically introduced through an artery or vein.
Angiography is a procedure wherein a dye is injected into the blood vessels and then some type of medical photograph such as an x-ray is taken of the blood vessels containing the dye. The dye is introduced through a catheter at various points on the body, depending on the areas and organs being analyzed. This evaluation of the blood flow to and from organs can detect diseases that affect the blood vessels, such as aneurysms, atherosclerosis, and thrombosis. After the angiography procedure is completed, the patient will often be asked to remain lying flat in bed for anywhere from 6 to 8 hours.
One particular angiographical procedure is a percutaneous femoral angiography. During this diagnostic fluoroscopy procedure, a catheter probe is used to determine blockages to the heart. The catheter enters the body in the lower groin area near the femur and runs up the body in the direction of the heart. Obviously, in surgical drapes used for this procedure, one or more fenestrations are located on a sheet to correspond to the lower groin/upper femur area. During the procedure, one or both of the fenestrations (if two openings are present in the sheet) may be used for insertion of various apparatus. If two fenestrations are present, and only one is used during the operation, access to the other fenestration may be blocked by various sheets, etc. as is known in the art.
A surgical drape which is designed specifically for brachial angiography is described in U.S. Pat. No. 5,074,316 to Dowdy. As shown therein, a catheter is introduced through the brachial artery to determine the pressure within the heart, determine abnormalities in the structure of the heart, and the like. The direct brachial angiography approach uses a catheter inserted through the patient's arm which is then manipulated by the surgeon through the artery into the heart.
Many of these types of procedures require that elongated or enlarged apparatuses such as wires, catheters, intravenous supply tubes, intraaortic balloon pump connections, and the like, be placed into the patient at the surgical site. In many of these operations, such apparatuses remain in the patient for some time after the surgery is complete. For example, during a percutaneous transluminal coronary angioplasty, anticoagulants such as heparin, are often administered to patients to enable coronary dialysis. In addition to heparin, such patients may also receive drugs such as beta blockers that increase blood thinning. After completing this particular procedure, the surgical wound site must clot to promote healing. Typically, direct pressure is applied to the arterial site to promote the clotting. In some cases, there is a need to maintain an intraaortic balloon pump at the site to aid in coronary blood flow for a substantial period after the operation.
In cases where wires, tubes, blood pumps, and the like, remain in the patient after surgery, soiled surgical drapes must be removed from the patient. Because such apparatus is received into the body through the apertures in the base sheet/pad, it has been a problem to remove the drape after the procedure has been completed. Although the base sheet is often made of an easy to tear material, the stronger absorbent pad usually requires the use of scissors or other cutting instrument to remove it from the patient. Obviously, the use of scissors near the surgical site after closure is not preferred due to risk to the patient.
This problem has been addressed in the past by utilizing drapes having perforations which aid in the removal of the drape from the patient. A drape of this type is shown in the prior art FIGS. 1 and 2 of U.S. Pat. No. 5,109,873 to Marshall. These Figures do not show the use of a reinforcing pad as in the present invention and, therefore, do not address the problem of tearing away this stronger pad. In addition, although the perforations in this singular drape sheet create a weakened line on the drape so that it may be pulled apart by hand without the need for scissors, the presence of the perforations reduces the ability of the drape to form a sterile field which is impervious to liquid and microorganisms.
Marshall (U.S. Pat. No. 5,109,873) also shows a tear-away drape with a singular sheet having a "V"-shaped score line extending from an edge of the sheet to the opening. Like the prior art shown in FIGS. 1 and 2 therein, Marshall does not show the use of an absorbent or reinforcement pad superimposed over a base sheet to provide the benefits obtained by use of such a pad in the present invention. Likewise, Marshall does not address the problem created by removal of the pad from the patient. Moreover, as shown in FIG. 4, the score line does not pass all the way through the sheet but, instead, extends to a depth of between 35% to 50% of the total thickness of the drape.
Thus, there is still a need for further improved surgical drape designs having a base sheet and a pad which allow quick tear-away removal from sites where an apparatus must remain connected to the patient after an operation.. Such improved drapes should still preserve the desired sterile field around the site, but be constructed to allow quick and easy removal from the patient.